Palvella Therapeutics Inc Stock Price, News & Analysis

Palvella Therapeutics (NASDAQ:PVLA) has completed enrollment in its Phase 2 TOIVA trial for QTORIN™ rapamycin, a potential first-in-class treatment for cutaneous venous malformations (VMs). The trial successfully enrolled 16 subjects at leading vascular anomaly centers, meeting its target of approximately 15 participants.

QTORIN™ rapamycin is a novel 3.9% rapamycin anhydrous gel designed to treat VMs, which affect an estimated 75,000+ U.S. patients. The drug aims to inhibit mTOR signaling while minimizing systemic exposure. The single-arm, open-label study will evaluate safety, tolerability, and efficacy through multiple measures, with top-line results expected in mid-December 2025.

Palvella Therapeutics (NASDAQ:PVLA) has appointed David W. Osborne, Ph.D. as Chief Innovation Officer. Dr. Osborne, co-founder and former Chief Technical Officer of Arcutis Biotherapeutics, brings over 25 years of experience in topical drug development and is an inventor on 52 U.S. patents and over 200 foreign patents.

In his new role, Dr. Osborne will lead Palvella's early-stage R&D pipeline and maximize the potential of the company's proprietary QTORIN™ platform, which develops targeted topical therapies for rare genetic skin diseases. The company plans to announce its second QTORIN™ product candidate by year-end 2025.

Dr. Osborne's notable achievements include contributing to the development of three dozen topical therapies, including ZORYVE® cream and foam, and holding senior roles at several pharmaceutical companies where he helped develop multiple FDA-approved therapies.

Palvella Therapeutics (NASDAQ:PVLA), a clinical-stage biopharmaceutical company developing therapies for rare genetic skin diseases, has announced upcoming presentations at two major healthcare investor conferences. CEO Wes Kaupinen will present at the Cantor Global Healthcare Conference on September 4, 2025, at 2:45 PM ET and the H.C. Wainwright Global Investment Conference on September 8, 2025, at 10:30 AM ET.

The presentations will be accessible via live webcast on Palvella's website, with replays available for approximately 90 days afterward.

Palvella Therapeutics (NASDAQ:PVLA) reported Q2 2025 financial results and provided updates on its clinical programs. The company's Phase 3 SELVA trial for QTORIN™ rapamycin in microcystic lymphatic malformations exceeded enrollment targets by 25%, with top-line results expected in Q1 2026. The Phase 2 TOIVA trial for cutaneous venous malformations remains on track for Q4 2025 results.

Financial highlights include $70.4 million in cash as of June 30, 2025, expected to fund operations into H2 2027. Q2 2025 saw a net loss of $9.5 million ($0.86 per share). The company plans to announce both a third clinical indication for QTORIN™ rapamycin and a second QTORIN™ platform candidate by year-end 2025.

Palvella Therapeutics (NASDAQ:PVLA), a clinical-stage biopharmaceutical company developing therapies for rare genetic skin diseases, will host its Q2 2025 financial results conference call on August 14, 2025, at 8:30 a.m. ET.

The company, which focuses on developing treatments for conditions with no current FDA-approved therapies, will provide both financial results and a corporate update during the call. Investors can access the live webcast with slides through Palvella's website under the "Events & Presentations" section, with a replay available for 90 days after the call.

Palvella Therapeutics (NASDAQ:PVLA), a clinical-stage biopharmaceutical company developing therapies for rare genetic skin diseases, announced its participation in the Canaccord Genuity 45th Annual Growth Conference. The company's Founder and CEO, Wes Kaupinen, will engage in a fireside chat on August 12, 2025, at 1:00 p.m. ET.

The presentation will be accessible via live webcast on Palvella's website, with a replay available for approximately 90 days after the event. The company focuses on developing treatments for conditions that currently lack FDA-approved therapies.

Palvella Therapeutics (Nasdaq: PVLA), a clinical-stage biopharmaceutical company developing therapies for rare genetic skin diseases, has been added to the Russell 3000® Index and Russell 2000® Index as part of the 2025 Russell indexes reconstitution, effective June 30, 2025.

The Russell indexes, which are widely used by investment managers and institutional investors, have approximately $10.6 trillion in assets benchmarked against them as of June 2024. Membership in these indexes is determined by market capitalization rankings and style attributes, with the Russell 3000® capturing the 3,000 largest US stocks.

Palvella Therapeutics (PVLA) has completed enrollment for its Phase 3 SELVA trial of QTORIN rapamycin, a treatment for microcystic lymphatic malformations (LMs). The trial significantly exceeded its enrollment target by 25%, with 51 subjects enrolled versus the planned 40. QTORIN rapamycin, which has received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA, is being evaluated as the first targeted therapy for this rare genetic disease. The 24-week trial includes subjects aged three years and older, with an open-label extension study available for eligible participants. The company expects to release top-line data in Q1 2026 and plans to submit a New Drug Application in H2 2026. Palvella has also received an FDA Orphan Products Grant worth up to $2.6 million to support the trial.

Palvella Therapeutics (PVLA) has secured its sixth U.S. patent (No. 12,329,748) for QTORIN™ rapamycin, extending protection until at least 2038. The patent covers anhydrous compositions containing 0.1-20% rapamycin and other mTOR inhibitors, along with their methods of use. QTORIN™ 3.9% rapamycin anhydrous gel, the company's lead product candidate, has received multiple FDA designations including Breakthrough Therapy, Orphan Drug, and Fast Track for treating microcystic lymphatic malformations. The company has also been awarded an FDA Orphan Products Grant worth up to $2.6 million to support its SELVA Phase 3 trial. If approved, QTORIN™ rapamycin could receive seven years of orphan drug market exclusivity in the U.S.